India this week approved its first vaccine against dengue, marking a milestone in the country’s decades-long struggle with a mosquito-borne disease that infects thousands and kills hundreds every year.
The Drug Controller General of India (DCGI) has granted market authorization to Qdenga, a quadrivalent dengue vaccine developed by Japanese pharmaceutical company Takeda, its Indian arm announced on Monday.
This approval allows the vaccine to be used to prevent dengue fever in individuals ages 4 to 60, regardless of whether they have been previously exposed to the virus.
Takeda Biopharmaceuticals India said it expects Qdenga to become available in the country in the first half of 2027, initially through private healthcare facilities. The company has partnered with Hyderabad-based vaccine maker Biological E since 2024 to expand manufacturing.
The approval comes ahead of the monsoon-related surge in cases that India – and much of South and Southeast Asia – braces for every year. According to India’s National Center for Vector-Borne Disease Control (NCVBDC), India has reported 6,927 dengue cases and 10 deaths as of February this year.
The World Health Organization recorded 232,425 cases and 233 deaths in India in 2024, part of a record global toll of 14.4 million cases and 11,201 deaths that year.
India accounts for nearly a third of the global dengue burden, and reported cases in the country have risen 11-fold in the past two decades, according to Takeda, a biopharmaceutical company in India.
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What is Qdenga and how does it work?
Qdenga, also known as TAK-003, is a live attenuated quadrivalent vaccine, meaning it contains weakened but live versions of the dengue virus. “Live attenuated” means the virus is intact, but has been attenuated to become too weak to cause disease. Commonly known vaccines based on live attenuated viruses include those for measles, mumps, and rubella (MMR), yellow fever, and oral polio vaccine (OPV).
Qdenga is designed to protect against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4) — each of which can independently cause dengue fever in humans.
According to the European Medicines Agency (EMA), which authorized the vaccine for use in the EU in December 2022, Qdenga uses the DENV-2 serotype as its genetic backbone.
Other components are “chimeric” or recombinant viruses — created by taking the DENV-2 backbone and swapping out the pre-membrane and envelope genes from DENV-1, DENV-3 and DENV-4, according to a 2025 review in the journal Vaccines (MDPI). [https://www.mdpi.com/2076-393X/13/5/532]. Coat proteins are what the immune system also recognizes and responds to, so this design effectively presents the body with the signatures of all four serotypes.
When the vaccine is given, the body’s immune system recognizes weakened viruses as foreign and produces antibodies against them, which can then neutralize the actual virus if there is later exposure to the virus causing dengue.
This design is important because vaccination against dengue is uniquely difficult. A person infected with one serotype develops lifelong immunity to that specific type but only short-lived cross-protection against the other three. A second infection with a different serotype can lead to a phenomenon called antibody-dependent enhancement, where pre-existing antibodies paradoxically worsen the disease – a risk that has shaped the entire field of dengue vaccine development.
Codinga is trying to address this challenge by stimulating what researchers call “balanced” immunity to all four serotypes simultaneously in a single cycle, more closely mimicking the immune profile of a person who has recovered from a natural infection.
But it is not an absolute solution. In the phase III trial, efficacy varied by serotype. TAK-003 showed sustained efficacy against all four serotypes in people who had already been exposed to dengue before vaccination, but in dengue-naïve (seronegative) recipients, efficacy was demonstrated mainly against DENV-1 and DENV-2, with less certainty about DENV-3 and DENV-4, according to a 2025 review in the journal Expert Review of Vaccines.
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Eligibility, Dosing and Effectiveness
Qdenga is given subcutaneously as a 0.5 milliliter injection, given in two doses three months apart. The World Health Organization advises not to shorten this period. If the second dose is delayed, there is no need to reschedule.
The Indian approval is based on data from Takeda’s global development program, which included clinical trials across dengue endemic and non-endemic areas. This included the phase 3 trial of TIDES (DEN-301), which enrolled more than 20,000 participants from eight countries – five in Latin America (Brazil, Colombia, Panama, Dominican Republic, and Nicaragua) and three in Asia (Philippines, Thailand, and Sri Lanka).
India was not among the trial sites, but they included Asian countries with dengue epidemiology broadly similar to parts of India.
According to trial data cited by Takeda, 12 months after the second dose, the vaccine showed an overall efficacy of 80.2% against virally confirmed dengue. After 18 months, it was 90.4% effective against dengue-related hospitalizations. After 4.5 years, the two doses continued to provide 84.1% efficacy against hospitalization, with safety and sustained efficacy documented for up to seven years against all four serotypes.
The results have been published in phases in The Lancet (2020) and The Lancet Global Health (2024), among other journals.
New Delhi’s statement is also supported by a separate phase III trial (DEN-302) conducted among Indian participants. The trial concluded, according to the company, that the vaccine was “acceptable, safe, and immunogenic” in adults, adolescents, and children between the ages of 4 and 60 years.
“The latest seven-year data for QDENGA shows continued protection against dengue infection and hospitalizations across all four serotypes; an important milestone for communities and health systems,” Mahinder Nayak, president of intercontinental markets at Takeda, said in a statement.
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Common side effects
According to the European Medicines Agency, the most common side effects – affecting more than one in five people – are pain and redness at the injection site, headache, muscle pain, and general malaise and weakness. Up to one in 10 recipients may have a fever. These effects are usually mild to moderate, disappear within a few days and are less frequent after the second dose than after the first dose.
Post-market monitoring has thrown up some rare signals. The WHO position paper on dengue vaccines, updated in May 2024, noted that although no cases of anaphylaxis were observed in the pivotal clinical trial of more than 20,000 participants, 16 cases were reported in the month following the vaccine’s deployment in Brazil in 2023 – a rate of 4.4 per 100,000 doses. The paper noted this and noted that the product listing now includes precautionary measures against anaphylaxis.
Who should – and should not – take it
The World Health Organization recommends Qdenga for children aged 6 to 16 years in areas with high dengue transmission. The Indian approval extends to a wider age range of four to 60 years, and follows EMA authorization from the age of four months Above.
The World Health Organization does not recommend routine programmatic use in children under 6 years of age because effectiveness is lower in that age group, and seropositivity – the proportion of people with evidence of previous infection – is generally low even in settings with high rates of transmission.
The vaccine should not be given to:
- People who are pregnant, or who plan to become pregnant within a month of vaccination, or who are breastfeeding
- People with congenital or acquired immunodeficiency, including those receiving immunosuppressive therapy such as chemotherapy or high-dose systemic corticosteroids
- People with symptoms of HIV infection, or asymptomatic HIV with evidence of poor immune function
- Anyone with a history of hypersensitivity to a previous dose of the vaccine
The European Medicines Agency also lists co-administration data supporting the use of Qdenga in combination with yellow fever and hepatitis A vaccines; Studies on co-administration with HPV vaccines are ongoing.
Where else is it approved?
According to Takeda, Qdenga has been approved in 43 countries since its launch in 2022, with more than 32 million doses distributed globally.
It received marketing authorization from the European Union on 5 December 2022, and pre-qualification from the World Health Organization on 10 May 2024 – a designation that meets global standards of quality, safety and effectiveness and enables procurement by international agencies such as UNICEF and the Pan American Health Organization.
Takeda said it is on track to reach a global manufacturing capacity of 100 million doses per year by 2030.
Other dengue vaccines
Qdenga is one of the few dengue vaccines to reach the market.
Dengvaxia (CYD-TDV): Dengvaxia, developed by Sanofi Pasteur, was the first dengue vaccine to receive marketing authorization in 2015.
According to the World Health Organization’s Global Advisory Committee on Vaccine Safety, it uses the yellow fever virus backbone that expresses the envelope proteins of the four dengue serotypes. But subsequent analysis, as documented by the World Health Organization in a 2017 safety update, showed that among people who had never had dengue, the vaccine could increase the risk of severe disease when infected later — the problem of antibody-dependent boosting.
The World Health Organization now recommends using Dengvaxia only for people with previously confirmed dengue fever. It is not approved in India.
Divya KS, an infectious disease specialist at Apollo Hospitals, told Reuters that regulators may have requested additional post-marketing safety data before approving it.
Butantan-DV, single-dose vaccine: Developed in Brazil, it is a single-dose vaccine that was approved by Brazilian health authorities in November 2025, but the country temporarily suspended it after two people died in June this year.
Of 501,044 people vaccinated between January and May, 3,703 – 0.7% – showed dengue-like symptoms, and 42 had more serious reactions.
Three serious cases were recorded, including the death of a 58-year-old man and a 48-year-old woman. A 38-year-old woman was hospitalized in intensive care and later released.
Brazilian Health Minister Alexander Padilha said in a press conference: “There is not enough data to prove a cause-and-effect link between the vaccine and these three serious cases, but it is a warning signal.”
Padilha called the events “completely unexpected” given that trial data showed 91.6% efficacy against severe dengue among 16,000 volunteers in 14 Brazilian states.
This vaccine has not been approved in India, and its regulatory status elsewhere is separate from the Qdenga vaccine. The single-dose regimen, if proven safe, could greatly simplify mass vaccination — a point of interest for public health systems, but not yet proven on a large scale.
Domestic vaccine and other candidates
Several dengue vaccine candidates are still in development. In India, the Indian Council of Medical Research (ICMR) is conducting phase III trials of an indigenous quadrivalent dengue vaccine — called DengiAll and developed in collaboration with New Delhi-based Panacea Biotec — with more than 10,000 participants across India.
DengiAll is derived from the same quadrivalent dengue vaccine platform (TV003/TV005) developed by the US National Institutes of Health (NIH) that also supports the Butantan-DV vaccine in Brazil.
Separately, Hyderabad-based Indian Immunologicals Ltd is preparing to start mid-stage clinical trials of a dengue vaccine candidate, said managing director K. Anand Kumar to Reuters.
Risk and burden of dengue fever
Dengue is present in more than 125 countries and is one of the fastest spreading vector-borne diseases worldwide. India reported more than 289,000 cases in 2023, although experts believe the actual burden was likely higher due to under-reporting and surveillance gaps.
Experts have consistently warned that vaccines alone will not solve the problem. “Qdenga can help reduce disease severity and hospitalizations, but is unlikely to prevent outbreaks as long as the mosquito vector continues to spread,” Divya KS of Apollo Hospitals told Reuters.
The World Health Organization makes the same point, saying that vaccination against dengue should be seen as part of an integrated strategy, which needs to engage community awareness and participation to stop the spread of the disease.
